Duns Number:080131031
Device Description: Bone void filler comprised of 45S5 bioactive glass and a gelatin carrier, intended for imp Bone void filler comprised of 45S5 bioactive glass and a gelatin carrier, intended for implantation
Catalog Number
ASI209-20
Brand Name
NanoFUSE Bioactive Strip
Version/Model Number
100x25x7mm
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
Issuing Agency
In GS1
MRI safety Status
Labeling does not contain MRI Safety Information
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437)
-
Device labeled as "Not made with natural rubber latex"
-
For Single-Use
Yes
Prescription Use (Rx)
Yes
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
K161996
Product Code
MQV
Product Code Name
Filler, Bone Void, Calcium Compound
Public Device Record Key
1e6f1507-1923-48fc-9e05-b082048cf5f5
Public Version Date
June 19, 2020
Public Version Number
2
DI Record Publish Date
July 16, 2019
Package DI Number
None
Quantity per Package
-
Contains DI Package
-
Package Discontinue Date
-
Package Status
-
Package Type
-
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 2 | A medical device with a moderate to high risk that requires special controls. | 10 |